Schizophrenia Clinical Trial
— MTQTOfficial title:
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
The study team will conduct a Multisite Randomized Controlled Trial to evaluate the advantages and disadvantages of two approaches for quitting smoking among people with serious mental illness (SMI). The study will compare a novel app tailored to people with SMI, Quit on the Go, to a standard of care smoking cessation intervention. We will test the effectiveness of the Quit on the Go app, an intervention that has demonstrated feasibility and acceptability in the target population, as a tool for smoking cessation in people with SMI. Participants with SMI will be recruited across 3 sites (Duke University, Univ. at Buffalo, and Wake Forest University).
Status | Recruiting |
Enrollment | 450 |
Est. completion date | April 1, 2025 |
Est. primary completion date | April 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder 2. Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version 3. Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months; 4. Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months; 5. Age 18 and older; 6. Willing and medically eligible to use NRT; 7. Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.). Exclusion Criteria 1. Problematic substance use, as defined by the Addiction Severity Index, within the last 30 days, twice within the past 6 months, or hospitalization for substance abuse within the past year. 2. Current acute psychotic episode or unsafe to participate in the study as defined by the Mini International Neuropsychiatric Interview for Psychotic Disorders (Sheehan et al., 1998); 3. Being pregnant or the intention to become pregnant in the next 6 months; 4. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation; 5. Currently using e-cigarettes or other tobacco products besides cigarettes > 10 days in the past 30 days. 6. Unsafe to participate in the study due to moderate or high risk of suicide determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Screen Version, defined as answering 'yes' to both question 3 for the last month and 'yes' to question 6 for lifetime (moderate risk), or 'yes' to questions 4 and 5 for the recent month, or 'yes' to question 6 for the last 3 months (high risk). |
Country | Name | City | State |
---|---|---|---|
United States | University at Buffalo | Buffalo | New York |
United States | Duke University | Durham | North Carolina |
United States | Wake Forest University | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), University at Buffalo |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Average app usability scores | Average self-reported scores of usability on the 10-item System Usability Scale. Scores range from 0-100 with higher scores indicating higher usability of the app. | 1 month follow-up | |
Other | Average user experience scores | Average self-reported scores of user experience using an adapted 5-item app user experience scale. | 1 month follow-up | |
Other | Average user experience scores | Average self-reported scores of user experience using an adapted 5-item app user experience scale. | 3 month follow-up | |
Other | Average user experience scores | Average self-reported scores of user experience using an adapted 5-item app user experience scale. | 6 month follow-up | |
Other | Average frequency of app use | Average frequency of app use over the 24-week study period. Measured by average number of app openings. | Weeks 0-24 | |
Other | Average duration of app use | Average duration of app use over the 24-week study period. | Weeks 0-24 | |
Other | Average number of app modules completed | Average number of app modules completed over the 24-week study period. | Weeks 0-24 | |
Other | Average acceptance of physical smoking cravings | Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings. | 1 month follow-up | |
Other | Average acceptance of physical smoking cravings | Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings. | 3 month follow-up | |
Other | Average acceptance of physical smoking cravings | Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings. | 6 month follow-up | |
Other | Nicotine patch use | Average number of days (out of 56 possible) per arm that participants used the nicotine patch. | 3 month follow-up | |
Other | Nicotine gum use | Average number of nicotine gum used per arm. | 3 month follow-up | |
Primary | CO-verified 7-day point-prevalence abstinence at 6-month follow-up | Abstinence is determined by a self-report of not smoking any tobacco product for greater than or equal to 7 days prior to Week 24 and biochemically verified by an expired carbon monoxide breath test reading of < 5 ppm at Week 24. If the participant does not meet both criteria, they are not considered abstinent.
As per convention, participants are assumed to be smoking if they report smoking at the time-point, cannot be reached to provide data at the time-point, fail to provide a breath sample at the time-point, or provide a breath sample at the time-point that is greater than or equal to 5 ppm. |
6 month follow-up | |
Secondary | Change in average number of cigarettes smoked per day | Change in self-reported number of cigarettes smoked per day, averaged within groups. | 1 month follow-up | |
Secondary | Change in average number of cigarettes smoked per day | Change in self-reported number of cigarettes smoked per day, averaged within groups. | 3 month follow-up | |
Secondary | Change in average number of cigarettes smoked per day | Change in self-reported number of cigarettes smoked per day, averaged within groups. | 6 month follow-up | |
Secondary | Average number of quit attempts per group | Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking at all for 24 hours or more. | 1 month follow-up | |
Secondary | Average number of quit attempts per group | Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking at all for 24 hours or more. | 3 month follow-up | |
Secondary | Average number of quit attempts per group | Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking at all for 24 hours or more. | 6 month follow-up | |
Secondary | Time to 7-day relapse | Average number of days of abstinence before relapse per group. Relapse defined by an instance of 7 consecutive days of smoking. | 1 month follow-up | |
Secondary | Time to 7-day relapse | Average number of days of abstinence before relapse per group. Relapse defined by an instance of 7 consecutive days of smoking. | 3 month follow-up | |
Secondary | Time to 7-day relapse | Average number of days of abstinence before relapse per group. Relapse defined by an instance of 7 consecutive days of smoking. | 6 month follow-up | |
Secondary | 30-day point prevalence abstinence rates | Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the timepoint. | 1 month follow-up | |
Secondary | Biochemically confirmed 30-day point prevalence abstinence rates | Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the time point. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | 3 month follow-up | |
Secondary | Biochemically confirmed 30-day point prevalence abstinence rates | Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the time point. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. | 6 month follow-up | |
Secondary | Prolonged abstinence rates | Percent of subjects in each group reporting prolonged abstinence. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period. | 1 month follow-up | |
Secondary | Prolonged abstinence rates | Percent of subjects in each group reporting prolonged abstinence. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period. | 3 month follow-up | |
Secondary | Prolonged abstinence rates | Percent of subjects in each group reporting prolonged abstinence. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period. | 6 month follow-up | |
Secondary | Continuous abstinence rates | Percent of subjects in each group self-reporting continuous abstinence (no smoking at all) between target quit date and specified time point. | 1 month follow-up | |
Secondary | Continuous abstinence rates | Percent of subjects in each group self-reporting continuous abstinence (no smoking at all) between target quit date and specified time point. Biochemically verified (CO < 5 ppm). | 3 month follow-up | |
Secondary | Continuous abstinence rates | Percent of subjects in each group self-reporting continuous abstinence (no smoking at all) between target quit date and specified time point. Biochemically verified (CO < 5 ppm). | 6 month follow-up |
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